{"id":60748,"date":"2023-09-06T12:14:13","date_gmt":"2023-09-06T12:14:13","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/py3701-regulatory-requirements-in-pharmaceutical-industries-syllabus-for-pharma-2021-regulation\/"},"modified":"2023-09-06T12:14:13","modified_gmt":"2023-09-06T12:14:13","slug":"py3701-regulatory-requirements-in-pharmaceutical-industries-syllabus-for-pharma-2021-regulation","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/py3701-regulatory-requirements-in-pharmaceutical-industries-syllabus-for-pharma-2021-regulation\/","title":{"rendered":"PY3701: Regulatory requirements in Pharmaceutical Industries syllabus for Pharma 2021 regulation"},"content":{"rendered":"

Regulatory requirements in Pharmaceutical Industries detailed syllabus for Pharmacy (Pharma) for 2021 regulation curriculum has been taken from the Anna University<\/a> official website and presented for the Pharma students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below. <\/p>\n

For Pharmacy 7th Sem scheme and its subjects, do visit Pharma 7th Sem 2021 regulation scheme<\/a>. The detailed syllabus of regulatory requirements in pharmaceutical industries is as follows. <\/p>\n

Course Objectives:<\/h4>\n

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Unit I<\/h4>\n

REGULATORY CONCEPTS\t9<\/strong>
\nQuality assurance \u2013 Quality control \u2013 Practice of cGMP \u2013 WHO Guidelines \u2013 Schedule M \u2013 USFDA.\n<\/p>\n

Unit II<\/h4>\n

REGULATORY ASPECTS\t9<\/strong>
\nPharmaceuticals: Bulk drug manufacture; Personnel, Buildings and Facilities, Process Equipment, Documentation and Records, Materials Management, Production and In-Process Controls, Packaging and Identification Labelling of API\u2019s and Intermediates, Storage and distribution, \u2013 Biotechnology derived products; Principles, Personnel, Premises and equipments, Animal quarters and care, production, labelling, Lot processing records and distribution records, quality assurance and quality control.\n<\/p>\n

Unit III<\/h4>\n

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Unit IV<\/h4>\n

ICH GUIDELINES\t9<\/strong>
\nQuality guidelines \u2013 Impurities in new drug substances (Q3A(R2)) \u2013 Impurities in new drug products(Q3B(R2)) \u2013 Validation of analytical procedures text and methodology (Q2 (R1)).\n<\/p>\n

Unit V<\/h4>\n

QUALITY AUDIT AND SELF INSPECTIONS\t9<\/strong>
\nSOPs \u2013 Documentation \u2013 Loan license auditing \u2013 Common technical documentation (CTD) \u2013 Drug master file (DMF) \u2013 Batch manufacturing record (BMR).\n<\/p>\n

Course Outcomes:<\/h4>\n

The student will be able to<\/p>\n